What’s Added to Plastic Mesh?

What’s Added to Plastic Mesh?

Krishna Engineering, EtO Sterilizer

Mesh Medical Device News Desk, March 7, 2017~ By now readers may understand that most mesh, whether for hernia repair or to treat prolapse and/or incontinence, is made of the plastic polypropylene (PP).

But you may not know about the additional chemicals that are introduced with polypropylene mesh.

There is no other way to say it – polypropylene (PP) is a cheap plastic mesh material and a dominant polymer used by the medical device industry.

Besides pelvic and hernia mesh, uses include catheters, tubing, syringes, and contact lenses. And PP use for medical devices is predicted to grow, despite the indications it might not be biocompatible.

Any chemical handled by workers as part of industrialized production is accompanied by a Materials Safety Data Sheet or MSDS. It is required by OSHA, the Occupational Health and Safety Administration.

In 2011, Dr. Donald Ostergard, past president of the American Urogynecologic Society (AUGS), told its members that “mesh is not inert.”

Mesh is able to incite an inflammatory response or foreign body reaction in the body. In other words, there is a continuing process of change and degradation. Electronic microscopy showed the deep cracks in the PP as it degrades in the body. It can shrink up to 50 percent.

Without chemical additives to slow the process, PP was seen to degrade in live animal tests (Liebert, 1976) and that degradation process occurred as soon as a few days after implantation.

An added antioxidant retarded the degradation process.

That insight, opened the door to a chemical smorgasbord of additives to PP mesh, the effects of which are unknown.

Prolene Mesh

CHEMICAL ADDITIVES TO MESH

According to testimony from the September 2014 case of Huskey v. Ethicon, (2:12-cv-05201), filed in the Southern District of West Virginia, the proprietary formulation of Ethicon/ Johnson & Johnson’s Prolene (PP) show the addition of Procol LA-10, a lubricant to help reduce tissue drag and promote tissue passage.

Santonox R is an added antioxidant. Its role is to protect the resin from thermal oxidation during the extrusion process during the making of sutures or threads.

Also added is the lubricant, Calcium Stearate.

Chemical polymer expert Dr. Shelby Thames, brought in as an expert for Johnson & Johnson, testified that DL TDP, also known as dilauryl thiodipropionate, is an added antioxidant that improves the long-term storage of the resin, reducing any impact of oxygen or ultraviolet light. See the background story on MND here.

A copper-based pigment is added to make the mesh more visible in the body.

The U.S. Food and Drug Administration (FDA) clears PP mesh for market and we know from inside those clearance documents that PP mesh implants are exposed to ethylene oxide (EtO) gas, a low-temperature sterilization agent.

EtO is considered toxic by the Environmental Protection Agency and a carcinogen. Exposure is regulated by the EPA in the workplace under the rules of OSHA.

Europe is light years ahead of the U.S in these concerns.

In May 2016, the European Parliament and EU Council of Ministers agreed to limit the use of devices that contain carcinogenic, toxic, mutagenic or hormone-disrupting properties.

That would include plastics.

The effort there comes after a disaster in France when a manufacturer used industrial grade silicone to fill breast implants.

The EU data will list all implantable devices that are on the market.

The U.S. has yet to establish a national database for medical devices that go wrong, though the MAUDE database is a start. Reporting can be voluntary, the database is difficult to decipher and adverse event reports often go first to the manufacturer, which can under FDA guidance decide if the complication is related to its medical device or not. ###

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I’m National News Editor, Jane Akre and I began Mesh Medical Device News Desk aka Mesh News Desk (MND) in the summer of 2011 just after the Food and Drug Administration issued an explicit warning to the public that complications associated with surgical mesh used for prolapse repair (POP) and incontinence (SUI) are NOT rare! That was the starting point for the litigation you see today and thousands of lawsuits have been filed by women whose lives have been altered, some permanently, by the use of this petroleum-based product.

19 Comments

It is disturbing to read this. As the body continues to fight the foreign body…and if your body has the propensity to build cancer cells…you will..no doubt.. be at high risk for some type of cancer developing in select organs or regions. It may take years.

Thank you Kitty, Hope you are well. I wrote a July Welcome and it was so negative, I just stopped…. something about offers are crap, people are dying lawyers are getting rich and the MDL system is broke. I thought, no one needs that message….but I didn’t just want to put a smiley face on it. So June welcome remains. Now I”m laughing a little at my writing… I ended with Happy Birthday America, pray for all of us!

I actually just found this article. It appals me that there are ppl that will make these devices using material they know not to be used, even warned in email and response was what don’t tell them (the company they got the product from). I mean come on where is your morals, your decency/respect for human life. I get their a business, in it to be the best, be the first, hungry with greed to make the most money so I fully feel that the makers of this mesh are truly souless evil beings how can they not be.
And you are right the MDL is broken the 510k is broken. The Healthcare in this country needs to be looked at but it’s not a priority.
Thank you for this story, all the ones in the past and all the future ones.
Kim

You are welcome Kim. But I don’t know if evil is the right word, at least not initially. Some women do not react negatively to their implants….. no one knows why that is…. and for some it is a very last resort when nothing else will work….But agreed, when you see how much destruction is taking place, figure out the problem before you continue using it…

Wondering if once Mesh is removed if we still have effects from these toxins as I had my mesh removed 18 months ago after having it killing me for 12 years. I’m only 48 yet feel 84 and it’s getting harder to walk. I’m weak all the time and my skin is breaking out in sore rashes plus lots more . I find website very helpful and I thought I would ask this question x thank you and regards x

I think it is a very good idea to conduct a sort of survey on healing- A) what helped you heal b) did you heal after mesh removal c) if not, why not d) what other things did you do to improve your health. I will post this soon…. anything else? I’ve heard some very interesting home remedies people have turned to…. as well as over the counter preparations.

Jane, the hard thing here is that surveys can be quite useless unless they have been scientifically studied and evaluated. To measure someone’s perceived healing, there needs to some consensus about what healing means. Some people may find that they can function with a high degree of pain while othersmay nor be able to get out of bed with the exact same level of pain. Defining healing is just so subjective. However, there are some good quality of life questionnaires that could help paint a more accurate set of data. Let me know if you want some help.

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I had an hernia ethicon prolene mesh put in and 1 year later, I had a tumor the size of a nerf football directly under the mesh. They classified the tumor as GIST and no one will even hint to the fact that this mesh is what caused the cancer. I had the mesh taken out when they removed the tumor. FDA and surgical association are a complete sham. along with johnson and johnson.